Healthy AdultMUSCLE-USNCT07647393
Ultrasound Muscle Biomarkers as Predictors of Isometric Quadriceps Muscle Strength and Handgrip in Healthy Adults: an Observational Study
An observational study of Healthy Adult and Muscle Strength, run by University of Alcala.
Trial summary
This observational study aims to determine whether ultrasound-derived muscle biomarkers can predict isometric quadriceps muscle strength and handgrip in healthy adults aged 18-89 years. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult, Muscle Strength, Skeletal Muscle Ultrasound
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jun 2026to Jun 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community-dwelling healthy adults aged 18-89 years residing in Spain. Participants will be recruited through community advertisements, institutional dissemination channels, and collaborating centres. The study aims to investigate the relationship between ultrasound-derived muscle biomarkers and isometric quadriceps muscle strength and handgrip in a healthy adult population.
Who may be able to join
- Healthy adults aged 18-89 years.
- Resident in Spain for at least 5 years.
- Living independently in the community and able to complete all study assessments.
- Able to understand and follow verbal instructions in Spanish.
- Able and willing to provide written informed consent prior to study participation.
Who cannot join
- Neurological, musculoskeletal, or systemic disorders affecting muscle strength or mobility.
- Recent surgery or acute injury affecting the upper or lower limbs.
- Recent use of medications affecting the musculoskeletal system (e.g., systemic corticosteroids for >1 week during the previous 6 months or muscle relaxants during the previous week).
- Cognitive or psychiatric conditions limiting participation.
- Pregnancy.
- Recent postpartum period (≤3 months after delivery).
Show all 12Show fewer
- Presence of clinically relevant pain, fatigue, physical deconditioning, or functional limitations that may interfere with study procedures or measurement validity.
- Acute illness at the time of assessment.
- Uncontrolled hypertension (≥140/90 mmHg).
- Resting peripheral oxygen saturation ≤90%.
- Moderate-to-severe pain (Numeric Rating Scale ≥4/10).
- Any medical condition considered by the investigator to contraindicate study participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This observational study aims to determine whether ultrasound-derived muscle biomarkers can predict isometric quadriceps muscle strength and handgrip in healthy adults aged 18-89 years.
The main questions it aims to answer are:
Read more
- Which ultrasound muscle characteristics are associated with isometric quadriceps muscle strength and handgrip?
- Can ultrasound-derived biomarkers be used to develop predictive models of muscle strength in healthy adults?
Participants will undergo:
- Ultrasound assessment of the quadriceps and forearm flexor muscles;
- Measurement of isometric quadriceps muscle strength and handgrip using standardized dynamometry protocols;
- Assessment of functional capacity, mobility and balance;
- Completion of questionnaires related to health status, physical activity, nutrition, fatigue and health-related quality of life.
The study will also assess the reliability of ultrasound measurements and explore the relationship between ultrasound variables, muscle strength, physical function and health-related factors.
Read the detailed description
Peripheral muscle strength is an important determinant of physical function, independence and health outcomes. Reduced quadriceps muscle strength and handgrip have been associated with functional limitations, frailty, hospitalization and mortality. Although muscle ultrasound is increasingly used to assess muscle morphology and quality, its ability to predict muscle strength remains incompletely understood.
The MUSCLE-US study is a monocentre observational study designed to investigate the relationship between ultrasound-derived muscle biomarkers and isometric quadriceps muscle strength and handgrip in healthy adults. Participants aged 18-89 years will be recruited from community settings and stratified by age and sex.
Ultrasound assessments will be performed on the quadriceps and forearm flexor muscles using standardized acquisition procedures. First-order variables (e.g., muscle thickness, cross-sectional area, pennation angle, fascicle length), second-order texture features and higher-order ultrasound biomarkers will be extracted and analysed.
Isometric quadriceps muscle strength and handgrip will be measured using standardized dynamometry protocols. Additional assessments will include functional capacity tests, mobility and balance measures, physical activity, nutritional status, fatigue, dyspnoea, health-related quality of life, lifestyle factors and comorbidity profiles.
The primary objective is to identify ultrasound biomarkers associated with quadriceps muscle strength and handgrip, and to develop predictive models of muscle strength. Secondary objectives include assessment of ultrasound measurement reliability and exploration of relationships between ultrasound biomarkers, muscle strength, physical function and health-related characteristics.
Recruitment, assessor training, ultrasound standardisation procedures and reliability analyses will be conducted during the initial phase of the project, followed by the main recruitment and data collection phase and subsequent statistical modelling and dissemination activities.
- Conditions
- Healthy Adult, Muscle Strength, Skeletal Muscle Ultrasound
- Keywords
- Muscle ultrasound, Skeletal muscle ultrasonography, Muscle biomarkers, Isometric quadriceps muscle strength, Handgrip, Muscle thickness, Echo intensity, Muscle quality, Predictive models
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy adults | Healthy/community-dwelling adults aged 18-89 years participating in an observational study evaluating ultrasound-derived muscle biomarkers and their relationship with isometric quadriceps muscle strength and handgrip. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric quadriceps muscle strength
Quadricpes maximal voluntary contraction measured using a handheld dynamometer according to a standardized testing protocol. Peak force will be recorded in kilograms-force (kgf).
Measured: Day 1
Handgrip
Maximal voluntary handgrip measured using a hydraulic hand dynamometer according to the American Society of Hand Therapists protocol. Peak force will be recorded in kilograms-force (kgf).
Measured: Day 1
Ultrasound-derived muscle biomarkers
Muscle ultrasound biomarkers obtained from standardized B-mode ultrasound images of selected quadriceps and forearm muscles. Candidate variables include muscle morphology, architecture, grayscale characteristics and texture-based parameters. The final set of ultrasound-derived biomarkers will be defined following assessor training, protocol standardization and pilot reliability analyses.
Measured: Day 1
Secondary outcomes (10)
Five-repetition sit-to-stand test
Functional capacity assessed by the time required to complete five sit-to-stand repetitions according to standardised procedures. Results will be expressed in seconds. Lower values indicate better lower-limb functional capacity.
Measured: Day 1
One-minute sit-to-stand test
Functional capacity assessed as the number of sit-to-stand repetitions completed in one minute according to standardised procedures. Higher values indicate better functional exercise capacity.
Measured: Day 1
Timed Up and Go test
Mobility and dynamic balance assessed using the Timed Up and Go test. Results will be expressed in seconds. Lower values indicate better mobility and dynamic balance.
Measured: Day 1
Modified Medical Research Council dyspnoea scale
Dyspnoea severity assessed using the modified Medical Research Council dyspnoea scale. Scores range from 0 to 4, with higher scores indicating greater breathlessness.
Measured: Day 1
Modified Borg dyspnoea scale
Perceived breathlessness assessed using the modified Borg dyspnoea scale. Scores range from 0 to 10, with higher scores indicating greater breathlessness.
Measured: Day 1
Dyspnoea-12
Dyspnoea assessed using the Dyspnoea-12 questionnaire. The total score ranges from 0 to 36, with higher scores indicating more severe breathlessness.
Measured: Day 1
Functional Assessment of Chronic Illness Therapy-Fatigue
Fatigue assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire. Scores range from 0 to 52, with higher scores indicating less fatigue.
Measured: Day 1
EuroQol 5-Dimension 5-Level
Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D) questionnaire. The index score will be calculated according to the appropriate national value set. Higher scores indicate better health status. Self-rated health assessed using the EQ-5D Visual Analogue Scale. Scores range from 0 to 100, with higher scores indicating better perceived health.
Measured: Day 1
International Physical Activity Questionnaire-short form
Physical activity assessed using the International Physical Activity Questionnaire-short form. Results will be expressed as minutes per week spent in vigorous/moderate/total physical activity, time per week spent walking and hours per day spent in sedentary behaviour (sitting).
Measured: Day 1
Mini Nutritional Assessment-short form
Nutritional status assessed using the Mini Nutritional Assessment-short form. Scores range from 0 to 14, with higher scores indicating better nutritional status.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicola S. Diciolla, University of Alcala
- Investigators
- Nicola S. Diciolla, PT, Ph.D., Principal investigator, University of Alcalá
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07647393
- Sponsor's protocol ID
- CEIP/2026/2/39
- Acronym
- MUSCLE-US
- Status last verified
- Jun 2026
- First submitted
- 9 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the results reported in publications, after de-identification, will be made available. Shared data may include demographic characteristics, anthropometric variables, isometric quadriceps muscle strength, handgrip, ultrasound-derived muscle variables, functional capacity measures, and patient-reported outcomes/questionnaire data collected as part of the study. Direct identifiers will be removed before data sharing. Data sharing will comply with applicable ethical approvals, informed consent provisions, and data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Muscle Biomarkers as Predictors of Isometric Quadriceps Muscle Strength and Handgrip in Healthy Adults: an Observational Study
- ClinicalTrials.gov ID
- NCT07647393
- Acronym / sponsor ID
- MUSCLE-US / CEIP/2026/2/39
- Conditions
- Healthy Adult, Muscle Strength, Skeletal Muscle Ultrasound
- Keywords
- Muscle ultrasound, Skeletal muscle ultrasonography, Muscle biomarkers, Isometric quadriceps muscle strength, Handgrip, Muscle thickness, Echo intensity, Muscle quality
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 15 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This observational study aims to determine whether ultrasound-derived muscle biomarkers can predict isometric quadriceps muscle strength and handgrip in healthy adults aged 18-89 years.
The main questions it aims to answer are:
- Which ultrasound muscle characteristics are associated with isometric quadriceps muscle strength and handgrip?
- Can ultrasound-derived biomarkers be used to develop predictive models of muscle strength in healthy adults?
Participants will undergo:
- Ultrasound assessment of the quadriceps and forearm flexor muscles;
- Measurement of isometric quadriceps muscle strength and handgrip using standardized dynamometry protocols;
- Assessment of functional capacity, mobility and balance;
- Completion of questionnaires related to health status, physical activity, nutrition, fatigue and health-related quality of life.
The study will also assess the reliability of ultrasound measurements and explore the relationship between ultrasound variables, muscle strength, physical function and health-related factors.
Detailed description
Peripheral muscle strength is an important determinant of physical function, independence and health outcomes. Reduced quadriceps muscle strength and handgrip have been associated with functional limitations, frailty, hospitalization and mortality. Although muscle ultrasound is increasingly used to assess muscle morphology and quality, its ability to predict muscle strength remains incompletely understood.
The MUSCLE-US study is a monocentre observational study designed to investigate the relationship between ultrasound-derived muscle biomarkers and isometric quadriceps muscle strength and handgrip in healthy adults. Participants aged 18-89 years will be recruited from community settings and stratified by age and sex.
Ultrasound assessments will be performed on the quadriceps and forearm flexor muscles using standardized acquisition procedures. First-order variables (e.g., muscle thickness, cross-sectional area, pennation angle, fascicle length), second-order texture features and higher-order ultrasound biomarkers will be extracted and analysed.
Isometric quadriceps muscle strength and handgrip will be measured using standardized dynamometry protocols. Additional assessments will include functional capacity tests, mobility and balance measures, physical activity, nutritional status, fatigue, dyspnoea, health-related quality of life, lifestyle factors and comorbidity profiles.
The primary objective is to identify ultrasound biomarkers associated with quadriceps muscle strength and handgrip, and to develop predictive models of muscle strength. Secondary objectives include assessment of ultrasound measurement reliability and exploration of relationships between ultrasound biomarkers, muscle strength, physical function and health-related characteristics.
Recruitment, assessor training, ultrasound standardisation procedures and reliability analyses will be conducted during the initial phase of the project, followed by the main recruitment and data collection phase and subsequent statistical modelling and dissemination activities.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy adults | – | –Healthy/community-dwelling adults aged 18-89 years participating in an observational study evaluating ultrasound-derived muscle biomarkers and their relationship with isometric quadriceps muscle strength and handgrip. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community-dwelling healthy adults aged 18-89 years residing in Spain. Participants will be recruited through community advertisements, institutional dissemination channels, and collaborating centres. The study aims to investigate the relationship between ultrasound-derived muscle biomarkers and isometric quadriceps muscle strength and handgrip in a healthy adult population.
Key inclusion criteria (5 listed)
- Healthy adults aged 18-89 years.
- Resident in Spain for at least 5 years.
- Living independently in the community and able to complete all study assessments.
- Able to understand and follow verbal instructions in Spanish.
- Able and willing to provide written informed consent prior to study participation.
Key exclusion criteria (12 listed)
- Neurological, musculoskeletal, or systemic disorders affecting muscle strength or mobility.
- Recent surgery or acute injury affecting the upper or lower limbs.
- Recent use of medications affecting the musculoskeletal system (e.g., systemic corticosteroids for >1 week during the previous 6 months or muscle relaxants during the previous week).
- Cognitive or psychiatric conditions limiting participation.
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Isometric quadriceps muscle strength
Time frame: Day 1
Quadricpes maximal voluntary contraction measured using a handheld dynamometer according to a standardized testing protocol. Peak force will be recorded in kilograms-force (kgf).
Handgrip
Time frame: Day 1
Maximal voluntary handgrip measured using a hydraulic hand dynamometer according to the American Society of Hand Therapists protocol. Peak force will be recorded in kilograms-force (kgf).
Ultrasound-derived muscle biomarkers
Time frame: Day 1
Muscle ultrasound biomarkers obtained from standardized B-mode ultrasound images of selected quadriceps and forearm muscles. Candidate variables include muscle morphology, architecture, grayscale characteristics and texture-based parameters. The final set of ultrasound-derived biomarkers will be defined following assessor training, protocol standardization and pilot reliability analyses.
10 secondary outcomes
Five-repetition sit-to-stand test
Time frame: Day 1
One-minute sit-to-stand test
Time frame: Day 1
Timed Up and Go test
Time frame: Day 1
Modified Medical Research Council dyspnoea scale
Time frame: Day 1
Modified Borg dyspnoea scale
Time frame: Day 1
Dyspnoea-12
Time frame: Day 1
Functional Assessment of Chronic Illness Therapy-Fatigue
Time frame: Day 1
EuroQol 5-Dimension 5-Level
Time frame: Day 1
International Physical Activity Questionnaire-short form
Time frame: Day 1
Mini Nutritional Assessment-short form
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results reported in publications, after de-identification, will be made available. Shared data may include demographic characteristics, anthropometric variables, isometric quadriceps muscle strength, handgrip, ultrasound-derived muscle variables, functional capacity measures, and patient-reported outcomes/questionnaire data collected as part of the study. Direct identifiers will be removed before data sharing. Data sharing will comply with applicable ethical approvals, informed consent provisions, and data protection regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicola S. Diciolla, PT, Ph.D. principal investigator
University of Alcalá
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Adult and Muscle Strength, run by University of Alcala.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicola S. Diciolla, PT, Ph.D. (+34 918 85 48 28, nicola.diciolla@uah.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Isometric quadriceps muscle strength (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.